This invention relates to containers used for shipping pharmaceuticals, especially those sensitive pharmaceuticals that can be compromised if temperature and/or humidity conditions are not properly observed during shipping. The invention is also concerned with a pharmacy shipping container that incorporates an electronic sensor that is attached onto a lid or cover of the crate, or is transported within the crate, and which can incorporate means for entering a receiving code or sequence, and transmitting a corresponding code or sequence electronically to a home station.
During transit, some pharmaceutical shipments need to be kept within a critical temperature range, and if so the crate or container needs to incorporate a system for monitoring the internal temperature. In addition to temperature monitoring, some pharmaceuticals need to be monitored for humidity, and some for both temperature and humidity. Some medicaments and medical products need to be at a temperature above ambient.
For transport of pharmaceuticals, or for use of pharmaceuticals in a mobile situation, there is a need for a sensing and monitoring device operates under battery power to provide a shipping chest or crate with a facility to monitor the quality of pharmaceuticals (e.g., temperature and/or humidity conditions) during transport. Then, if the temperature or humidity was outside the acceptable range during shipping, access can be monitored and controlled to the cabinet and to the possibly tainted medication, so that the quality of the sensitive contents can be assured.
Often it is desirable to track the temperature (and/or humidity) of the contents of the shipping chest or crate, and automatically to provide an alert warning if the temperature (or relative humidity) has been outside an acceptable range during transit. Other parameters can be tracked as well, e.g., carbon dioxide content, ammonia content, or other gas present on the inside of the container or crate.
A further need is for ensuring patient safety, i.e., to ensure any drugs that have not been kept at the proper storage conditions, e.g., having been outside of an acceptable temperature range, are not made available to patients until purity has been checked out by pharmacy staff.
The pharmaceutical industry has achieved a global reach and impact, with medicines and vaccines being shipped to all areas of the world. Many of these medicines and vaccines are temperature sensitive and have precise storage requirements. Unfortunately, during shipment the products can be subjected to extreme temperature and humidity changes, unforeseen delays during transit, especially international transit, and need for field delivery to remote points of use, several mode changes may occur. In addition, the pharmaceutical companies are subject to relentless cost pressures, so there is a need to make shipping and distribution as efficient as possible while ensuring that the products that are delivered are of consistent quality.
At the present time, most refrigerated medications are shipped in twelve-inch by twenty-four-inch insulated boxes, with ice. These can include a digital thermometer device that logs the temperature, but does not lock the box closed, and does not guarantee that any medication in the box that was subject to poor temperature control is isolated and not distributed to a patient. Some medications are shipped in a box or crate without ice, and are shipped in a refrigerated container. These boxes may have a special security tape that is intended to reveal tampering, but these are not locked containers, and there is no means included to prevent distribution of the medications if they had been subjected to adverse temperature (or humidity) conditions.